Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001019594
Ethics application status
Approved
Date submitted
5/08/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Type 2 diabetes and metabolic syndrome remission program, a co-designed pilot with Aboriginal people living on Ngarrindjeri Country – ‘Nra:gi Ya:yun’ (healthy foods)
Scientific title
Type 2 diabetes and metabolic syndrome remission program, a co-designed stepped wedge pilot with Aboriginal people living on Ngarrindjeri Country – ‘Nra:gi Ya:yun’ (healthy foods)
Secondary ID [1] 312738 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 334634 0
Metabolic syndrome 334773 0
Condition category
Condition code
Metabolic and Endocrine 331217 331217 0 0
Diabetes
Metabolic and Endocrine 331218 331218 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 28-week non-randomised stepped wedge pilot, consisting of 2 sites (4 clusters) with 3 phases: a control phase, a remission phase, and a maintenance phase (ongoing). Each cluster will serve as its own control, initially experiencing a 4-week period of monitoring but no exposure. Exposure to the fixed 12-week remission phase will be staggered by cluster on a fortnightly basis. Each participant will experience the project's 3 phases. The remission phase is considered the active phase of the trial, whereby participants will be supported to adopt a ketogenic diet. For the duration of the 12-week remission phase participants will have access to the following:

1) Continuous glucose and ketone monitoring (CGM/CKM) devices to encourage motivation, compliance and ensure up-to date information is provided to program staff. This cutting-edge equipment provides participants with daily readings on their remission progress from their place of residence. CGM/CKM readings are uploaded automatically every 5 minutes to allow program staff to view results as necessary.

2) Participants will receive a tablet, linked to digital Point of Care Testing (POCT) equipment to measure blood pressure, temperature, pulse and oxygen saturation. This daily POCT will include questions on CGM/CKM discomfort and e-yarns on wellbeing (free text response questions followed by opportunity for participants to record a short video on the tablet). The daily POCT will take less than 10 minutes. Results will be uploaded automatically to the tablet via Bluetooth and accessible to both participants and program staff using an internal dashboard (no personal internet data required).

3) Weekly monitoring by clinical staff (experienced GP and endocrinologist) with clinical back-up via the Virtual Clinical Care team from the the Integrated Cardiovascular Clinical Network SA (iCCnet SA). During weekly check-ins Program Leads (PLs) will be supported by clinical investigators to measure blood pressure, weight, waist circumference, capillary ketones and HbA1c (digital monitors). A clinical distress pathway has been established outlining clinical parameters and necessary follow up procedures. Weekly clinical monitoring will be informed by the daily CGM/CKM readings, daily POCT results, weekly physiological measures and blood tests recorded at T1-T5. Participants will triaged to, A) our clinical team for remission, B) GP/ED for other clinical standard of care, or C) our project staff for support/coaching issues.

4) Weekly supply of ketogenic meal boxes containing subsidised ingredients for 2 meals per day, catering for individuals and their families.

5) Weekly yarning check-ins and support sessions on remission progress, challenges etc. with Program Leads (PLs) and the Diabetes Project Manager (DPM). The length and mode of each session (i.e. in person or over the phone) will be directed by the participant themselves as program staff adopt a participant-centred approach.

6) Fortnightly 1-hour gatherings (education or physical activity) held on Country at site locations, facilitated by PLs and the DPM, focusing on community concerns raised during the formative co-design phase of the study. These fortnightly sessions will be held across the 2 sites and will be guided by PLs and participant feedback. Planned activities include strength building sessions, walking on Country, education sessions on diabetes and ketogenic eating. We envision a maximum of 20 participants per session. Dictated by community interest, sessions will be repeated as required.

7) Incremental remission journey resources from Week 1 of remission phase containing program infographics such as a keto food pyramid, pantry list, meal plans, recipes, and sorry business navigation. These physical resources will be provided at fortnightly gatherings or at the weekly collection of ketogenic meal boxes. Participants will have access to electronic versions if so desired. We envision the development of a program book, with all relevant resources collated throughout the program.

8) Online support for those who cannot attend in person (i.e. due to work, family/caring commitments, transportation access) through social media platforms (i.e. WhatsApp). Participants will receive electronic versions of the resources and short videos reviewing key content delivered during fortnightly gatherings.

Recruitment, retention, adherence, and completion rates will be recorded by PLs throughout the trial.

During the maintenance phase, access to above intervention components is slowly reduced. A staggered transition was designed to empower participants to continue their T2DM and metabolic syndrome remission journey, with sustainability of health outcomes in mind. Meal boxes will not be supplied, as participants source relevant ingredients independently, supported by program staff. Participants will retain access to CGM/CKM patches and POCT equipment for the first two weeks of the maintenance phase. Fortnightly gatherings offered during the remission phase will continue but transition towards community-led, informal gatherings facilitated by PLs from the local health network. The intent is for community to take ownership of the process, directing the future content and structure of the gatherings. Online supports will similarly be community-directed during the maintenance phase. Participants will have the choice of continued access to online and/or in-person gatherings or to transition away during this final phase. It is anticipated that by the end of the maintenance phase, participants will be equipped with the appropriate knowledge, resources, and support to maintain their remission independently.

This trial is embedded in the larger project entitled Knowledge interface co-design of a diabetes and metabolic syndrome initiative with and for Aboriginal people living on Ngarrindjeri Country. The project protocol and methodologies of Strengths-Based Approaches as Knowledge Interface Methodology have been previously described.(1,2) The primary component of the initiative is the adoption of an evidence-based ketogenic diet to improve metabolic outcomes. The project began after Aboriginal Elders and senior community representatives living on Ngarrindjeri Country in rural South Australia reached out to Flinders University and the Riverland Mallee Coorong Local Health Network (RMCLHN) to assist with creating sustainable changes to T2DM and metabolic outcomes. Community expressed their desire for a project that was Aboriginal owned and led, guided by values of reciprocity and self-determination.
Between June and December 2023, ten co-design workshops were held across 3 sites on Ngarrindjeri Country, facilitated by Aboriginal PLs and DPMs. PLs were instrumental to workshop success, offering transport for participants and providing researchers with local contextual knowledge and guidance on community protocols. 42 individuals consented to participate across the co-design workshops. Participants included Elders, senior community representatives, health workers, youth workers and manual laborers. Workshops lasted between 40 minutes and 2 hours.

References:
1. Ryder C, Wingard S, Cameron D, Kerrigan C, Worley P, Spaeth B, et al. Community co-design to target diabetes and metabolic syndrome in Australian Indigenous peoples. Nature medicine. 2023;29(2):292-3.
2. Cameron D WA, Mendham A, Wingard S, Kropinyeri R, Scriven T, et al. Knowledge interface co-design of a diabetes and metabolic syndrome initiative with and for Aboriginal people living on Ngarrindjeri country. Public Health in Practice. 2024;Accepted
Intervention code [1] 329188 0
Lifestyle
Intervention code [2] 329190 0
Treatment: Other
Intervention code [3] 329191 0
Behaviour
Comparator / control treatment
Each of the 4 clusters will serve as its own control, initially experiencing a 4-week period of monitoring but no exposure, known as the control phase. Exposure to the fixed 12-week active remission phase will be staggered on a fortnightly basis by cluster.
Control group
Active

Outcomes
Primary outcome [1] 338995 0
Change in metabolic outcomes (This will be assessed as a composite outcome using 4 assessment methods)
Timepoint [1] 338995 0
For assessment method 1: T1 baseline, T2 pre-exposure (4 weeks after enrolment into pilot), T3 post-exposure (16 weeks after enrolment into pilot), T4 follow-up (6 weeks post-remission phase), and T5 end of the pilot (end of 28-week pilot).

For assessment method 2: Weekly during 12 week remission phase

For assessment method 3: 5 minute collection points during 12 week remission phase

For assessment method 4; Daily during 12 week remission phase
Secondary outcome [1] 438202 0
Change in diet
Timepoint [1] 438202 0
Weekly during 12 week remission phase and at T1-T5.
Secondary outcome [2] 438203 0
Change in self-reported sleep quality
Timepoint [2] 438203 0
Weekly during 12 week remission phase and at T1-T5.
Secondary outcome [3] 438204 0
Change to participant out of pocket expenses on food and health (composite outcome using 3 assessment methods)
Timepoint [3] 438204 0
For assessment method 1: Weekly during 12 week remission phase and at T1-T5.

For assessment method 2: At T1-T5.

For assessment method 3; At T1 and T5.
Secondary outcome [4] 438205 0
Change in participant knowledge
Timepoint [4] 438205 0
T1-T5
Secondary outcome [5] 438207 0
Change in effect of diabetes and metabolic syndrome on participant life course (assessed together as a composite secondary outcome using 3 assessment methods)
Timepoint [5] 438207 0
For assessment method 1: Daily during 12 week remission phase and T1-T5

For assessment method 2: T1-T5

For assessment method 3: T1-T5
Secondary outcome [6] 438208 0
Feasibility of intervention (assessed as composite outcome using 3 assessment methods)
Timepoint [6] 438208 0
For assessment method 1: Weekly during 12 week remission phase, T2-T4

For assessment method 2: At conclusion of study

For assessment method 3: T5

Eligibility
Key inclusion criteria
Aboriginal person living on Ngarrindjeri country, aged 18 years or over, records measurements consistent with type 2 diabetes (HbA1c levels greater than or equal to 6.5%A1c) or metabolic syndrome (defined by meeting 3 of 5: abdominal obesity, hypertension, insulin resistance, raised triglycerides, decreased HDL cholesterol).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Pregnancy
*breast feeding women
*Type 1 diabetes
*End stage liver failure or undergoing dialysis
*T3cD (primary pancreatic disease)
*Insulin deficient diabetes
*self-reported eating disorders (anorexia, nervosa, bulimia)
*On SGLT2 inhibitors for reasons other than diabetes (i.e. renal disease or heart failure)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Non-randomised stepped wedge cluster trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patient demographics will be presented as general descriptive statistics means (SD) or counts (%), for individual clusters and the step-wedge cohort as a whole. Intervention effectiveness from unexposed, exposed and maintenance phases in reducing diabetes and metabolic syndrome markers, will be examined through application of the orthogonalized least squares framework by Hu and Hoover.(1) The Hu and Hoover (2018) orthogonalized least squares approach is recommended as a more accurate approach framework for non-randomised stepped-wedge designs, over non-randomized difference-in-differences approaches.(1) Intervention effectiveness from weekly PoCT measures will be examined using mixed modelling.

Participant and remission program delivery costs will be combined with EQ-5D-5L responses (over 7 months) to inform a cost-utility analysis of an upscaled remission program to be delivered via a Randomised Control Trial. A retrospective cost-effectiveness analysis will also be conducted to compare the 28-week costs and outcomes of the remission program to those of the 7-month period before the remission program. Cost-effectiveness analysis outcomes will be expressed in terms of incremental costs of participant engagement.

Qualitative data from weekly rapid yarns and evaluation yarns (concerning quality of life, knowledge, and program acceptability) will be inductively coded in Nvivo software using a constructivist approach to grounded theory,(2) and themes generated across time points compared for analysis.

References
(1) Hu Y, Hoover DR. Non-randomized and randomized stepped-wedge designs using an orthogonalized least squares framework. Statistical methods in medical research. 2018;27(4):1202-18.
(2) Bainbridge R, Whiteside M, McCalman J. Being, Knowing, and Doing: A Phronetic Approach to Constructing Grounded Theory With Aboriginal Australian Partners. Qualitative health research. 2013;23(2):275-88

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
11/11/2024
Actual
Date of last data collection
Anticipated
26/05/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 42963 0
5253 - Murray Bridge
Recruitment postcode(s) [2] 42964 0
5264 - Meningie
Recruitment postcode(s) [3] 42965 0
5259 - Raukkan

Funding & Sponsors
Funding source category [1] 317096 0
Government body
Name [1] 317096 0
Department of Health and Aged Care - Medical Research Future Grant
Country [1] 317096 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 319357 0
Government body
Name [1] 319357 0
Riverland Mallee Coorong Local Health Network
Address [1] 319357 0
Country [1] 319357 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315845 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 315845 0
Ethics committee country [1] 315845 0
Australia
Date submitted for ethics approval [1] 315845 0
23/04/2024
Approval date [1] 315845 0
11/06/2024
Ethics approval number [1] 315845 0
04-24-1120
Ethics committee name [2] 315850 0
Flinders University Human Research Ethics Committee
Ethics committee address [2] 315850 0
Ethics committee country [2] 315850 0
Australia
Date submitted for ethics approval [2] 315850 0
11/06/2024
Approval date [2] 315850 0
13/06/2024
Ethics approval number [2] 315850 0
7525

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135978 0
A/Prof Courtney Ryder
Address 135978 0
College of Medicine and Public Health, Flinders University, Sturt Rd, Bedford Park, SA 5042
Country 135978 0
Australia
Phone 135978 0
+61 08 7221 7602
Fax 135978 0
Email 135978 0
courtney.ryder@flinders.edu.au
Contact person for public queries
Name 135979 0
Shanti Omodei-James
Address 135979 0
College of Medicine and Public Health, Flinders University, Sturt Rd, Bedford Park, SA 5042
Country 135979 0
Australia
Phone 135979 0
+61 8 8432 4033
Fax 135979 0
Email 135979 0
shanti.omodeijames@flinders.edu.au
Contact person for scientific queries
Name 135980 0
Professor Paul Worley
Address 135980 0
Riverland Mallee Coorong Local Health Network, PO Box 346, Murray Bridge SA 5253
Country 135980 0
Australia
Phone 135980 0
+61 08 8580 2402
Fax 135980 0
Email 135980 0
paul.worley@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24067OtherRyder, C., Wingard, S., Cameron, D. et al. Community co-design to target diabetes and metabolic syndrome in Australian Indigenous peoples. Nat Med 29, 292–293 (2023). https://doi.org/10.1038/s41591-022-02174-7https://doi.org/10.1038/s41591-022-02174-7  Correspondence detailing research gap and the form... [More Details] 388230-(Uploaded-05-08-2024-16-05-30)-s41591-022-02174-7.pdf
24068OtherCameron, D. et al. (2024) Knowledge interface co-design of a diabetes and metabolic syndrome initiative with and for Aboriginal people living on Ngarrindjeri country. Public health in practice (Oxford, England). [Online] 7100496–100496.https://doi.org/10.1016/j.puhip.2024.100496  Protocol for formative, co-designed component of t... [More Details] 388230-(Uploaded-05-08-2024-16-07-57)-Qualitative phase protocol.pdf



Results publications and other study-related documents

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